A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides
NCT00389311 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2015-04-01
Summary
The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.
Conditions
- HIV Infections
Interventions
- DRUG
-
Normosol-R
- DRUG
-
Nonoxynol-9
- PROCEDURE
-
Gastrointestinal instrumentation
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Edward Fuchs, PA-C, MBA · The Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2008-02-29
- Completion
- 2009-06-30
Countries
- United States
Study Locations
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